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Premier Kathleen Wynne vows to investigate chemotherapy error

A multi-agency investigation into how nearly 1,200 Canadian cancer patients received watered-down chemotherapy treatments started yesterday afternoon at a Mississauga industrial complex.

Two Health Canada agents and an inspector from the Ontario College of Pharmacists arrived at Marchese Hospital Solutions, the pharmacy contracted to mix and supply the drug cocktails, just after 3 p.m., several hours after Premier Kathleen Wynne vowed to “find out how this happened.”

In the meantime, health care officials on all sides are now scrambling for answers to a growing list of questions.

How did the dilution of the drugs impact patients’ treatments and longevity? Was the product properly labelled? How did it pass through so many hands for nearly a year before one pharmacist technician in Peterborough noticed there was a problem? Who’s watching the medication that so many rely on to make them better?

Marchese, in a statement released Wednesday afternoon, suggested some hospitals simply didn’t administer the drugs the way they were supposed to.

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They were administered in a way that was not “consistent with the contract,” the statement said.

The details of the contract are a secret, according to Medbuy, a company that purchases drugs for hospitals.

Medbuy refused to comment Wednesday, saying it needs more time to gather details.

Nearly 1,000 patients in Ontario undergoing chemotherapy within the last year for diseases that included cancers of the breast, lung and bladder received diluted doses of treatment, Ontario’s cancer care agency revealed Tuesday. Seventeen patients at Windsor Regional Hospital alone have died since starting their therapy. London Health Sciences Centre reported the highest number of affected patients with more than 600.

The problem was discovered by a pharmacy technician at a Peterborough hospital late last month. The premixed drug cocktail, which contained too high a percentage of saline solution, was shipped out to at least four hospitals in Ontario and one in New Brunswick.

Linda Wentoniuk, 63, died Christmas Day after being diagnosed with stage-four gastrointestinal cancer in June 2012. Her husband Nick hasn’t yet received a call or letter from Windsor Regional Hospital but he worries she was among those affected.

“We were surprised at how well she handled the chemo,” he said, explaining she had some hair loss but few other side effects. “I don’t know if they used full strength, if it might have helped. I don’t suppose anyone will know.”

Tom McHugh, vice-president of cancer services at Lakeridge Health in Oshawa, where more than 30 patients were affected in the eight days that its doctors were administering the drug, said the onus is on the pharmacy to monitor its supply.

“We are not doing random spot-checks (to ensure) a product is what is supposed to be,” McHugh said. “We specify a product, we contract with a manufacturer and we bring that product in.”

Added Ken Tremblay, CEO of Peterborough Regional Health Centre, where only one patient was affected:

“You rely on the core labelling of the core products to be accurate.”

On Wednesday, the Institute for Safe Medication Practices Canada issued a statement calling for a national standard for the labelling of cancer chemotherapy solutions.

Sylvia Hyland, vice-president and COO, highlighted the danger of not properly labelling intravenous bags, particularly given the common practice of manufacturers routinely over-filling bags pre-filled with saline solution.

While the drugs in question — cyclophosphamide and gemcitabine — are scrutinized for use by Health Canada, oversight of the facilities that dispense and mix these drugs falls to the province.

The Ontario College of Pharmacists conducted a routine inspection of Marchese’s Mississauga facility in January. It met accreditation standards, as did the company’s two other sites in Kitchener and Hamilton, college registrar Marshall Moleshi said.

Marchese grew from a small Hamilton neighbourhood shop in 1961 to a multi-facility operation equipped with warehouse and distribution centre, according to a 2005 report in the Hamilton Spectator. Marita Zaffiro took the helm in 1988, and made dramatic changes to the business, expanding it into a company that provides province-wide services, including the mixing of chemotherapy drugs.

Moleshi said a pharmacy is not required to notify the college when it shifts its focus to large-scale supply though the risks increase.

“There will be a thorough review done,” said Health Minister Deb Matthews. “If there are any lessons to be learned they will be applied — I can assure you.”

“This rocks peoples’ trust in the health-care system.” She called the situation “unbelievable.”

In Kingston, Premier Kathleen Wynne expressed concern.

“It is a very worrisome situation . . . and we will work to find out how this happened but in the immediate term what is really critical is that people are contacted . . . and they get in touch with their oncologist so they can determine the impact of this situation,” Wynne said.

Officials with the health ministry said many patients who received the diluted treatment have been contacted. Matthews said they are receiving expedited appointments with their respective oncologists.

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